Postoperative Recovery After Thoracic Surgery | NCT03602664

Studies
Postoperative Recovery After Thoracic Surgery

NCT03602664

Sponsor

Sahlgrenska University Hospital

Status

Unknown status

Last Update Posted

Aug 3, 2018Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Postoperative Pain
Postoperative Complications

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 5, 2018Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Apr 2020Estimated

First Submitted Date

Jun 5, 2018

First Submission Date that Met QC Criteria

Jul 26, 2018

First Posted Date

Jul 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2018

Last Update Posted Date

Aug 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stefan Lundin, Adj Professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A questionaire specifically developed using in depth interviews with patients that has undergone surgery has been developed. This questionaire will be used for longterm follow in patients undergoing thoracic surgery. 200 patients will be asked to fill in this questionaire preoperatively as well as 3 and 12 months after surgery to assess symptomburden after surgery with specific aim to study postoperative pain as well as other physical, mental and cognitive problems that may affect the patient and their daily activities, health, return to work, family life and economy.

Detailed Description

In Sweden around 400 000 patients under go surgical operations in hospitals. A large proportion, around 20%, develop persistent postoperative pain which affects their quality of life and their recovery towards a normal life.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Thoracic surgery		Patients undergoing thoracic surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pain 3 months after surgery as compared to preoperatively assessed with a studyspecific questionnaire	Pain at 3 months after surgery as compared to prior to surgery	Pain at 3 months after surgery as compared to preoperatively

Secondary Outcomes

Measure	Description	Time Frame
Postoperative functional impairment after surgery assessed with a studyspecific questionnaire	Physical, mental and cognitive problems were assessed with a studyspecific questionaire 3 months after surgery as compared to preoperatively	Status at 3 months after surgery as compared to before the operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing thoracic surgery (thoracotomy or thoracoscopy) who accept to participate in the study

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients planned to undergo thoracotomy or thoracoscopy at Sahgrenska University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefan Lundin, MD PhD	Contact	+46 31 3428112		stefan.lundin@gu.se
Sigrun Asgeirsdottir, MD	Contact	+46 31 3421000		sigrun.asgeirsdottir@vgregion.se

Overall Officials

Name	Affiliation	Role
Stefan Lundin, MD PhD	Sahlgrenska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital	Recruiting	Gothenburg		S-413 45	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided